Cardiff Oncology, Inc. — FY2023 Form 10-K
Reporting period: Fiscal year ended December 31, 2023; filed February 29, 2024. Cardiff Oncology is a clinical-stage biotechnology company developing onvansertib, an oral PLK1 inhibitor, primarily in combination with standard-of-care therapies. It has no approved products and has generated only limited royalty revenue unrelated to onvansertib.
Financial performance and liquidity
| Metric | FY2023 | FY2022 |
|---|---|---|
| Revenue | $0.49 million | $0.39 million |
| Research and development expense | $32.86 million | $27.11 million |
| Selling, general and administrative expense | $13.04 million | $13.18 million |
| Operating loss | $45.41 million | $39.90 million |
| Interest income, net | $4.07 million | $1.58 million |
| Net loss attributable to common stockholders | $41.47 million | $38.73 million |
| Basic and diluted loss per share | $0.93 | $0.89 |
| Cash used in operating activities | $30.89 million | $33.82 million |
Revenue was immaterial relative to operating expenses; gross margin is not meaningful for this development-stage business. R&D expense rose 21%, mainly from clinical programs and outside services, while SG&A declined slightly. Higher interest income partly offset the increased operating loss.
At year-end, cash and cash equivalents were $21.66 million and short-term investments were $53.17 million, totaling $74.77 million; working capital was $67.0 million. Management said resources were sufficient for at least 12 months after issuance of the financial statements and projected funding into the third quarter of 2025. It expects continued losses and says additional capital will be needed. The balance sheet reports operating lease liabilities of $2.15 million; no conventional borrowings are shown. Common shares outstanding were 44.68 million. Outstanding options and warrants may create dilution.
Pipeline, developments, and outlook
- RAS-mutated metastatic colorectal cancer (mCRC): The company discontinued enrollment in the second-line ONSEMBLE trial in August 2023 and shifted focus to first-line treatment. CRDF-004 is a randomized Phase 2 trial comparing onvansertib plus standard-of-care regimens with standard of care alone; interim data were anticipated in mid-2024. The company said FDA discussions supported a potential seamless Phase 3 approach, contingent on CRDF-004 results.
- Earlier mCRC results: In the single-arm TROV-054 trial, reported results included a 29% objective response rate and median progression-free survival of 9.3 months across evaluable patients. The bevacizumab-naïve subgroup had a 73% response rate and 15-month median progression-free survival, but comprised only 15 patients. In ONSEMBLE, the February 2024 update reported responses in 2 of 4 bevacizumab-naïve patients receiving onvansertib combinations and none in bevacizumab-exposed patients; subgroup sizes were small.
- Pancreatic cancer: Enrollment in the second-line CRDF-001 trial closed in October 2023. Preliminary results among 21 evaluable patients included a reported 19% response rate and 5.0-month median progression-free survival; a February 2024 update said three of four partial responses were confirmed. These are early, non-randomized results.
- Other indications: Investigator-led trials are evaluating onvansertib in pancreatic cancer, relapsed small cell lung cancer, and triple-negative breast cancer. The small-cell-lung-cancer trial reported one partial response and disease control in 4 of 7 patients in preliminary data.
- Collaboration: Pfizer Ignite is responsible for clinical execution of CRDF-004, with Cardiff responsible for trial costs and retaining economic ownership and control of onvansertib.
Risks, contingencies, and notable items
- The company has an accumulated deficit of $339.5 million, recurring losses, negative operating cash flow, and no product revenue. It may need further financing; equity issuance could dilute shareholders, and financing may not be available on acceptable terms.
- Onvansertib remains investigational. Clinical results may not be replicated or predict later-stage outcomes; trials, regulatory review, enrollment, manufacturing, or third-party vendor performance may be delayed or unsuccessful.
- The company relies on third-party manufacturers and clinical research providers. It also depends on its exclusive Nerviano license for onvansertib; breach or termination could jeopardize key rights.
- Potential risks include competition, intellectual-property challenges, regulatory and reimbursement changes, cybersecurity incidents, and volatility or Nasdaq listing concerns.
- Clinical-trial accruals were $4.3 million at year-end. The auditor identified estimation of accrued clinical-trial expenses as a critical audit matter because it depends on management’s assessment of vendor services and trial progress. The auditor issued an unqualified opinion on the financial statements; management reported effective disclosure controls and internal control over financial reporting.
- Management reported no legal claims expected to have a material adverse effect. The company reported no material cybersecurity incidents in recent years, while noting future incidents cannot be ruled out.
Important facts for investors to verify
- Whether CRDF-004 interim results support continued development and the proposed registrational trial strategy.
- Durability and reproducibility of mCRC and pancreatic-cancer responses, including the significance of small subgroup sizes and prior bevacizumab exposure.
- Actual cash burn, trial spending, and whether the stated runway into Q3 2025 remains achievable.
- Financing plans and potential dilution from future equity issuance, options, and warrants.
- Clinical-trial accrual estimates, third-party supply and execution risks, and continued compliance with the Nerviano license.